Anterior Cruciate Ligament (ACL) Reconstruction with a New Generation of LARS Artificial Ligament
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MOVMEDIX
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of Serious Adverse Device Effect (SADE)
研究概览
简要总结
This clinical investigation is intended to demonstrate the safety of the new generation of LARS ligaments and compare this new generation (grafted ligament) of artificial ligament to the LARS current artificial ligament (non-grafted ligament) which is CE marked since 1997, in case of ACL injury. The new generation of LARS artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation, fibroblast organization and collagen type I & III secretion. This physiological response leads to a better osseo-integration of the ligaments. Therefore, the study is expected to demonstrate the investigational device safety and biomechanical improvements.
详细描述
Forty subjects over 40 years old with acute ACL injury will be included. A follow-up program is planned over 1 year per subject (days 7, 15, 30, 60, 90, 180, 365) based on physical therapy, biological analysis and biomechanical measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the grafted ligament
- •Subject provides written informed consent approved by the Ethics Committee prior to any clinical investigation related procedure
- •Subject must agree to undergo all clinical investigation plan - required clinical follow-up visits
- •Subject must agree not to participate in any other clinical investigation for a period of 1 year following the procedure
- •Male and female subjects over 40 years old
- •MRI positive for full acute ACL injury
- •Arthrometric evaluation (KT1000) with a side-to-side difference greater than 3 mm
- •Symptomatic subjects with no previous knee injury
- •Subjects without concomitant pathologies (fracture, infections, immunodepression, HIV, HCV) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
- •I and II degree chondral lesions
排除标准
- •Subjects under 40 years old
- •III and IV degree chondral lesions
- •Associated ligament injuries
- •Meniscus suture (e.g. hndle bucket meniscal tears) that compromise the rehabilitation program
- •History for sepsis
- •Subjects with concomitant pathologies (fracture, infections, immunodepression, HIV, HCV,) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
- •Previous knee injuries
- •Septic arthritis
- •Infected tissues
- •Pregnancy
- •Overweighed, obese subject (>100kg)
- •History of metabolic bone disease
- •Inflammatory joint disease
- •Known neoplastic disease
- •Medical treatment (e.g steroid)
- •HIV positive subject
- •Hepatitis positive subject
- •Allergy to Titanium, PET, Ugurol, Gentamicin, Polystyrene Sulfonate, other medication
结局指标
主要结局
Incidence of Serious Adverse Device Effect (SADE)
时间窗: 6 months
Primary outcome will evaluate the safety of the grafted ligament by reporting the number of SADE(s) in the Experimental Arm.
次要结局
- Assessment of patients' opinion about their knee and associated problems(12 months)
- Assessment of patients' pain intensity(12 months)
- Assessment of overall knee function(12 months)
- Assessment of posterior-anterior knee laxity(12 months)
- Assessment of knee flexors-extensors strength(12 months)
- Assessment of stabilometry(12 months)